Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer
ACUPUNCTURE
A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients With Head and Neck Cancer
3 other identifiers
interventional
258
1 country
36
Brief Summary
This study is being done to find out what effects, good and/or bad, acupuncture has on participants and their xerostomia caused by radiation therapy for the treatment of the cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2012
Longer than P75 for not_applicable
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2012
CompletedFirst Submitted
Initial submission to the registry
August 17, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2022
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedFebruary 27, 2026
February 1, 2026
9.7 years
August 17, 2015
August 1, 2023
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Xerostomia Questionnaire Scores
Self reported Xerostomia questionnaire consists of eight items (scored on an 11-point scale; 0-10), has been validated in several cohorts, and is regarded as the gold-standard measure for xerostomia.The questions are equally divided into 4 items about oral dryness while eating or chewing and 4 items about dryness while not eating or chewing. Item scores are summed and transformed linearly to produce a final summary score between 0 and 80. Higher scores represent more xerostomia. Questionnaire is completed prior to randomization and at each time point week 4, week 8, week 12, and end of study.
Baseline to 4, 8, 12, 26 weeks post acupuncture
Secondary Outcomes (2)
Functional Assessment of Cancer Therapy (FACT-G) Total
Baseline, 4 , 8 , 12, and 26 weeks
The Acupuncture Expectancy Scale (AES)
Week 4
Study Arms (3)
Standard Oral Hygiene
ACTIVE COMPARATORAll patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site.
Standard Oral Hygiene + True Acupuncture
EXPERIMENTALAll patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes.
Standard Oral Hygiene + Sham Acupuncture
OTHERAll patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points.
Interventions
Oral hygiene care provided per individual institutions standard of care.
Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
Eligibility Criteria
You may qualify if:
- Must be at least 18 years of age and able to give informed consent.
- Must be able to read, write and understand English.
- Must have a diagnosis of head/neck cancer.
- Must have received bilateral radiation therapy, and subsequently developed grade 2 or 3 xerostomia, according to modified Radiation Therapy Oncology Group (RTOG) scale:
- Grade 0 - None
- Grade 1 - Slight dryness of mouth (good response on stimulation and no significant dietary alterations necessary)
- Grade 2 - Moderate dryness of mouth (poor response on stimulation and altered oral intake required such as frequent water, oral lubricants, or soft-moist foods)
- Grade 3 - Complete dryness of mouth (no response on stimulation and difficult oral alimentation; IV fluids, pureed diet or tube feedings may be required)
- Grade 4 - Fibrosis
- Must have received external beam radiation at a mean dose of at least 24 Gy to one of the parotid glands. The other gland can receive less than 24 Gy.
- Must have completed radiotherapy at least 12 months prior to entry.
- Must have anatomically intact parotid and submandibular glands. A focused (head/neck) history and exam conducted by a physician or dentist within the past year is required.
- Must be acupuncture naĂ¯ve.
- Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
You may not qualify if:
- History of xerostomia, Sjogren's disease or other illness known to affect salivation prior to head/neck radiation.
- Currently receiving or planning to use drugs, herbs, alternative medicines, or devices that could affect salivary production. Treatment known to affect salivation should be stopped at least 14 days prior to enrollment. Over the counter products used for salivary substitution are allowed, but will need to be discontinued for at least 24 hours prior to saliva and questionnaire data collection.
- Have received any investigational new drug within the past 30 days or planning to receive such during the study period.
- Active systemic infection or skin infection at or near the acupuncture sites.
- Receiving chemotherapy during study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente-San Rafael
San Rafael, California, 94903, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402, United States
Saint Luke's Hospital
Cedar Rapids, Iowa, 52402, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MD Anderson West Houston
Houston, Texas, 77079, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503, United States
Related Publications (1)
Cohen L, Danhauer SC, Garcia MK, Dressler EV, Rosenthal DI, Chambers MS, Cusimano A, Brown WM, Ochoa JM, Yang P, Chiang JS, Gordon O, Crutcher R, Kim JK, Russin MP, Lukenbill J, Porosnicu M, Yost KJ, Weaver KE, Lesser GJ. Acupuncture for Chronic Radiation-Induced Xerostomia in Head and Neck Cancer: A Multicenter Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410421. doi: 10.1001/jamanetworkopen.2024.10421.
PMID: 38739392DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The trial was not successful at recruiting a large sample of ethnically/racially underserved participants. In addition, the majority of the patients were also men, but participation of women reflected the incidence of head and neck (HN) cancer in men and women. Most of the patients only received 4 weeks of acupuncture and no maintenance treatments were provided. Future research should examine if the effects can be enhanced with further treatments.
Results Point of Contact
- Title
- Lead Biostatistician (Dr. Emily Dressler)
- Organization
- Wake Forest NCORP Research Base
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne C Danhauer, PhD
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2015
First Posted
October 28, 2015
Study Start
November 11, 2012
Primary Completion
July 29, 2022
Study Completion
July 29, 2022
Last Updated
February 27, 2026
Results First Posted
September 19, 2024
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 6 months after publication for a 2 year duration
- Access Criteria
- upon request
Wake Forest (WF) National Cancer Institute Community Oncology Research Program (NCORP) Research Base (RB) is committed to following the NIH Statement on Sharing Research Data. As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the National Clinical Trials Network (NCTN)/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.